8/21/2025

speaker
Operator
Conference Operator

Welcome to the Kantargia Q2 Report 2025 presentation. During the questions and answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now I will hand the conference over to the speakers. CEO Damian Marin, CFO Patrik Renvlad, and CBO Tan Burkian, please go ahead.

speaker
Damian Marin
Interim Chief Executive Officer

Hello, everybody, and welcome to this presentation today of our 2Q and first half interim report 2025. Moving straight on, we have our safe harbor statement. We are, of course, a listed company on NASDAQ Stockholm Exchange. And as has just been mentioned, you have three speakers here today, myself, interim CEO, Tom McKean, our Chief Business Officer, and Patrick Remblad, our Chief Financial Officer. So moving to the events of the second quarter and the events since the end of that period as well. In the second quarter, we appointed Morton Lind Jensen as our Chief Medical Officer. We then moved on to select Treatment-resistant atopic dermatitis is the second indication for our CAN10 phase 2 program, CAN10 being our anti-IL-1 antibody for immune inflammatory disorders. We also announced that the pharmacokinetic modeling of CAN10 confirmed the choice of every four-week dosing in phase 2, coming from our first in-human study that has been running for some time and is now nearing its end. Also importantly, during the quarter, the US FDA awarded to Naginolimab, our most advanced product in oncology, a fast track designation for the treatment of patients expressing high levels of IL-1 RAP in combination with chemotherapy to treat patients with PDAC, pancreatic ductal adenocarcinoma. Finally, we signed a loan facility of 50 million Swedish krone that to provide us with extra flexibility as we held deal discussions, which I'm sure everybody now knows about. And in fact, the first significant event after the reporting period was indeed that we announced that Totsuka Pharmaceutical had acquired CanTen for an upfront of US$33 million, plus an additional US$580 million in potential milestone payments and an out on future sales. That deal is expected to close in Q3 2025, and Tom will give you further details as we go through the presentation. We also announced preliminary results from the TRIFOR Phase 2 study in TMVC. They showed that we did not demonstrate in the second part of this study a difference in the overall response rate between naginolimab in combination with chemotherapy and the reference group on chemotherapy alone. That study continues on and we will have overall survival data around the end of this year. And I'll say a few more words about that as well as we get further into the presentation. And finally, we announced on Monday evening this week that we'd appointed Dr. Hildegard Steininger as our new CEO effective from September the 1st, 2025. So indeed, this will be my last results call with you. And in future, you will be hearing from Hilda and the team. And we're absolutely delighted to have Hilda on board, it has to be said. And I will give you a bit more on Hilda's background later in the presentation. Moving down to just a few words on CanTen and why CanTen is such an interesting product and became the subject of our transaction with Otsuka. So Cam10 provides a really a unique opportunity to block IL-1 superfamily signaling across multiple diseases and multiple therapy areas. The IL-1 family of ligands and receptors is associated with acute and chronic inflammation. And there's very strong evidence of IL-1 family cytokines. That's IL-1, alpha and beta, IL-33. and IL-36 alpha, beta, and gamma, driving multiple different inflammatory diseases. What's been seen in the clinic to date is that individual blockade of these IL-1 family members has resulted in a degree of efficacy, but probably not the sort of efficacy that you really want to see across diverse immune inflammatory diseases. And we really believe that CANTEN's broader mechanism can be highly relevant treatment of such diseases, be they dermatological, fibrotic, cardiovascular, or even others in various barrier tissues in the respiratory tract, for instance, or in joints and in the intestine. So there really is a huge potential for this mechanism and for CAN10. As I mentioned a few moments ago, we've been conducting a first in human study for some time, single ascending dose and then multiple ascending dose. We completed the single ascending dose a while ago, 10 different cohorts, and moved on into the multiple ascending dose, where we have performed two dose cohorts in healthy volunteers, controlled by placebo, where we gave subcutaneous doses on day one and seven, then every 14 days. And this study is the study that will allow us to move into phase two. they, or I say us, to move into phase two, as it now is, it will be, of course, Otsuka who will be handling that following the transaction with them. What we have shown is that we can achieve full IL-1 occupancy on different immune cells and that we have complete blockade of IL-1 family cytokines. We also, of course, very importantly, have seen no safety concerns. And as I mentioned, our pharmacokinetic results support for weekly dosing. We have a linear PK profile with high bioavailability, and the simulations performed on all patients we have treated show that we can stay above the minimum level that we need to occupy all the receptors and block those cytokines over a period of four weeks. So that leads us to the transaction with Otsuka. And I'll hand you over here to our CBO, Tom Burkeen, to tell you more about that. Over to you, Tom.

speaker
Operator
Q&A Moderator

You may not be unmuted, Tom.

Disclaimer

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